Brindisi

Researchers are evaluating the prognostic value of a genomic classifier called S18 and its refined version S* in women with early-stage HER2-positive breast cancer. The study focuses on whether these tools can predict event-free survival EFS and disease-free survival DFS in patients treated with trastuzumab-based therapies, with or without pertuzumab. This observational study includes women aged 18 or older with operable stage I to III HER2-positive breast cancer. The study uses data and tumor tissue samples collected from two cohorts of patients who received neoadjuvant andor adjuvant trastuzumab pertuzumab therapies. It combines clinical, pathological, and genomic information to refine and validate the prognostic capability of the S18 classifier. No investigational treatments are administered as part of this observational research. Participants provide informed consent and their clinical and genomic data are analyzed. Researchers assess outcomes such as event-free survival and disease-free survival over at least three years following systemic therapy. They also explore overall survival and pathological complete response based on the classifier values. The studys total duration includes follow-up for at least three years after treatment initiation.

This observational study aims to describe the use of teclistamab and talquetamab in treating patients with relapsed or refractory multiple myeloma RRMM outside of clinical trial settings. It collects real-world data to better understand how these treatments are used and their outcomes in typical healthcare environments. The study enrolls participants who have received at least one dose of teclistamab or talquetamab outside clinical trials during specified time periods from before December 2022 through December 2025. No study interventions are administered instead, researchers analyze existing medical records to document treatment details and patient experiences with these therapies. Participants medical records are reviewed to capture baseline characteristics, response rates, time to response, duration of response, survival outcomes, safety management, and treatment use up to 40 months. The study focuses on collecting comprehensive retrospective data without requiring active treatment or additional procedures, providing insight into real-world treatment patterns and outcomes for RRMM patients.

Researchers are conducting a Phase III, randomized, open-label multicenter study to evaluate the effectiveness and safety of giredestrant compared with fulvestrant. Both drugs are combined with the investigators choice of a CDK46 inhibitor palbociclib, ribociclib, or abemaciclib in participants with estrogen receptor-positive ER, HER2-negative advanced breast cancer who have become resistant to prior adjuvant endocrine therapy. Participants will be randomly assigned to one of two groups one group will receive giredestrant 30 mg orally daily on Days 1-28 of each 28-day cycle, while the other will receive fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and Day 1 of subsequent 28-day cycles. Both groups will also receive a CDK46 inhibitor chosen by the investigator, with dosing schedules depending on the specific inhibitor selected. Preperimenopausal women and men will receive a luteinizing hormone-releasing hormone LHRH agonist during treatment. Participants will be assessed for progression-free survival over up to 5 years, with additional measures including overall survival, response rates, duration of response, clinical benefit, and quality of life. Safety will be monitored through adverse event reporting, vital signs, and laboratory tests during treatment and up to 28 days after the last dose. The study is led by Hoffmann-La Roche and aims to provide detailed information on the treatments effects in this patient population.

This research aims to evaluate the long-term safety of luspatercept in participants who have previously taken part in other luspatercept clinical trials for conditions such as Myelodysplastic Syndromes MDS, Beta-thalassemia, and Myeloproliferative Neoplasm-associated Myelofibrosis. It is a Phase 3b, open-label, single-arm rollover study designed to continue monitoring participants who tolerated previous luspatercept treatment and may benefit from ongoing therapy, as well as those in post-treatment follow-up phases. Participants transitioning from prior luspatercept studies will enter a Transition Phase defined by an enrollment visit. Those continuing treatment will receive luspatercept injections subcutaneously at the same dose and schedule as their parent trial, administered by study staff at clinical sites. The study includes a Treatment Phase for ongoing luspatercept administration and a Follow-up Phase comprising a 42-day safety follow-up after the last dose and a long-term post-treatment follow-up phase lasting at least 5 years to monitor overall survival and progression to malignancies. Throughout the study, participants will be regularly assessed for adverse events, progression to high-risk MDS or AML, and development of other malignancies or treatment-related masses. Safety parameters are evaluated during the 42-day follow-up, while long-term survival and disease progression are monitored every six months for at least five years. The study will conclude when all participants have completed five years of combined treatment and follow-up.

Triple-negative breast cancer TNBC is a very aggressive and deadly form of breast cancer with limited effective treatments available. Researchers are evaluating a combination of the immune therapy drug atezolizumab with chemotherapy drugs cyclophosphamide and vinorelbine. This phase II trial aims to measure the overall response rate of this combination in patients with advanced or metastatic TNBC who have previously been treated with anti-PD-1 or anti-PD-L1 therapies. Participants will receive atezolizumab intravenously at 840 mg on days 1 and 15 of each 28-day cycle. Cyclophosphamide will be given intravenously at 300 mgm2 on days 1, 8, 15, and 21, while vinorelbine will be taken orally at 30 mg on days 1, 3, and 5 weekly within each cycle. This treatment will continue as first-line therapy for metastatic TNBC. The study will also assess secondary outcomes such as duration of response, progression-free survival, overall survival, and safety of the treatment. During the trial, participants will undergo regular assessments for tumor response using RECIST 1.1 criteria, organ function tests, and performance status evaluations. Researchers will monitor the overall response rate over 30 months, along with progression-free and overall survival. Safety and tolerability will be closely followed. The total participation duration depends on treatment response and survival, with ongoing monitoring throughout the study period.

Researchers are evaluating the use of BIOTRONIK dual-chamber pacemakers that combine left bundle branch area pacing LBBAP with Closed Loop Stimulation CLS in patients who have sinus node dysfunction SND and atrioventricular AV conduction disorders. This observational study aims to understand how this combined pacing method works in everyday clinical practice and whether it can help reduce atrial fibrillation detected by the device over 24 months. The goal is to gather real-world evidence to optimize pacemaker programming and improve patient outcomes. Participants receive permanent dual-chamber pacemakers with a ventricular lead placed in the left bundle branch area, activating the CLS rate-responsive algorithm. The study focuses on patients implanted with these devices who have no prior history of atrial fibrillation. The study follows about 150 patients for 24 months after implantation, collecting data on device-detected atrial fibrillation episodes, heart rate patterns, and pacing behavior. This is a prospective observational submodule of the BIOSTREAM.CSP registry without a control group. During the study, researchers monitor device-recorded atrial fibrillation incidence and burden from CLS activation up to 24 months. They also analyze heart rate histograms at one and two years after implantation. Patients are enrolled in the BIOSTREAM.CSP registry and are followed through routine clinical care with data collected on pacing rates and arrhythmia episodes. The study aims to provide insights into the clinical performance of CLS combined with LBBAP to inform decisions on pacemaker programming and reduce atrial arrhythmias.

This observational study evaluates the long-term outcomes, performance, and safety of BIOTRONIK devices used for conduction system pacing CSP in real-life clinical settings. It focuses on patients who receive these devices for cardiac pacing, including those with pacemakers, cardiac resynchronization therapy devices, or implantable cardioverter defibrillators, addressing conditions like bradycardia, tachycardia, and heart failure. Participants receive the Solia CSP S pacing lead for left bundle branch area pacing LBBAP as part of their routine care with BIOTRONIK devices. The study includes patients intended for new implantation or those recently implanted with investigational generators and leads positioned deep within the intraventricular septum. The study observes patients over an average of four years, monitoring device-related safety and electrical parameters through annual evaluations. Participants are involved in regular follow-up visits and use the BIOTRONIK Home Monitoring system via CardioMessenger to track device performance. Researchers measure rates of successful implantation, capture types, pacing thresholds, sensing amplitudes, and pacing impedance throughout the study. Safety is assessed by monitoring serious adverse device effects during the study period. The total participation time averages about four years, with annual assessments to support long-term device evaluation.

Researchers are studying patients with hormone receptor-positive, HER2-negative early breast cancer HRHER2- EBC who are at high risk of their cancer returning. This observational study includes both past and future phases to assess the clinical and pathological features, treatment choices, and outcomes of patients treated with CDK46 inhibitors ribociclib or abemaciclib combined with endocrine therapy in the adjuvant setting. The study also focuses on patients whose cancer returned during or within 12 months after finishing this adjuvant treatment. Participants are those who have started or are starting adjuvant treatment with ribociclib or abemaciclib along with endocrine therapy since January 1, 2021. This study does not involve assigning treatments but observes patients receiving these therapies in real-world settings. It gathers data on treatment patterns, recurrence, and clinical outcomes without altering patient care. During the study, researchers will collect and analyze data on patient health, tumor characteristics, and treatment responses. They will track invasive disease-free survival over 3 years as the main outcome, along with distant relapse-free survival, progression-free survival, and overall survival up to 5 years. Participants will provide consent for their data to be used, and their health status will be monitored through routine medical records and follow-ups. The study is expected to continue until August 2030.

Researchers are evaluating vamifeport in adults with homeostatic iron regulator gene-related hereditary hemochromatosis HFE-HH, a condition characterized by iron overload. This phase 2, multicenter, randomized, placebo-controlled, double-blind study aims to assess the effect of vamifeport on liver iron concentration using magnetic resonance imaging MRI. The study focuses on adults with confirmed HFE-HH and iron overload to explore the potential impact of the treatment. Participants are randomly assigned to receive either a low dose or a high dose of vamifeport, or a placebo, all administered orally twice daily up to 360 days. The study compares these three groups over this treatment period to evaluate the treatments effect on liver iron levels. The study includes careful monitoring and assessment of safety and efficacy throughout the treatment duration. During the trial, participants undergo regular assessments including MRI scans to measure liver iron concentration at baseline and day 360. Safety is monitored by tracking adverse events, laboratory tests, and electrocardiograms up to day 390. Additional evaluations include measurements of transferrin saturation, serum ferritin, joint pain, fatigue, and quality of life questionnaires. Blood samples are collected to measure vamifeport concentrations at specific time points. Participants are followed for a total of about 13 months, including treatment and safety monitoring periods.

Researchers are investigating how emotional distress ED affects treatment outcomes in patients with metastatic breast cancer mBC who are receiving first-line therapies. This study focuses on the impact of baseline emotional distress on the effectiveness of various treatments according to breast cancer subtypes. Emotional distress is common among breast cancer patients and has been linked to poorer treatment adherence and quality of life, but its role in metastatic breast cancer treatment success is not well understood. Participants will be grouped based on their breast cancer subtype and receive standard first-line treatments accordingly triple-negative PD-L1 positive patients receive chemotherapy with immune checkpoint inhibitors, triple-negative PD-L1 negative patients receive chemotherapy alone, HR-positiveHER2-negative patients receive a CDK46 inhibitor plus endocrine therapy, and HER2-positive patients receive chemotherapy combined with trastuzumab and pertuzumab. Emotional distress and quality of life will be assessed through questionnaires at baseline and during treatment. During the study, patients will complete specific questionnaires to measure emotional distress, quality of life, and fear of cancer progression. Researchers will monitor progression-free survival and objective response rates over two years, comparing outcomes based on emotional distress levels at the start and early in treatment. Quality of life and psychological factors will also be evaluated over three months. All participants must provide informed consent and meet eligibility criteria before joining.